FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENT ENDOSCOPES
K Number: K003830
·
Decision Apr 9, 2001
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
7
Review Days
119
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Basic Information
- Device Name
- ENT ENDOSCOPES
- K Number
- K003830
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Global Endoscopy, Inc.
- Date Received
- December 11, 2000
- Decision Date
- April 9, 2001
- Product Code
- EOB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Global Endoscopy, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003805 | GYNECOLOGICAL LAPAROSCOPES | Jul 22, 2001 | Substantially Equivalent |
| K003802 | HYSTEROSCOPES | Jul 22, 2001 | Substantially Equivalent |
| K003831 | ARTHROSCOPES | Jul 20, 2001 | Substantially Equivalent |
| K003803 | GENERAL SURGICAL LAPAROSCOPES | Mar 7, 2001 | Substantially Equivalent |
| K003806 | URETEROSCOPES | Feb 22, 2001 | Substantially Equivalent |
| K003807 | CYSTOSCOPES | Feb 22, 2001 | Substantially Equivalent |